At Inteldot, we specialize in delivering high-quality systems integration and staff augmentation services to clients in the life sciences industry. We are currently seeking experienced Validation Specialists to join our growing team and support projects across the LATAM region.
Position Summary:
The Validation Specialist will be responsible for providing validation services in support of projects related to equipment, utilities, facilities, processes, and computer systems. The ideal candidate will have hands-on experience in one or more of the following areas:
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Commissioning and Qualification (C&Q)
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Process Validation
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Computer System Validation (CSV)
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Cleaning Validation
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Risk Assessments, Protocol Development, and Execution
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Regulatory compliance (FDA, EMA, GAMP 5, etc.)
Key Responsibilities:
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Develop and execute validation protocols (IQ/OQ/PQ, PV, CSV, etc.)
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Review and analyze data and documentation to ensure compliance with regulatory and client standards
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Collaborate with cross-functional teams to ensure timely project execution
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Provide technical support and guidance to client teams
Requirements:
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Bachelor’s degree in Engineering, Life Sciences, or related field
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Minimum of 3 years of experience in validation within the pharmaceutical, biotechnology, or medical device industries
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Knowledge of current industry regulations and best practices (cGMP, FDA, GAMP, etc.)
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Strong communication and documentation skills
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Ability and willingness to travel within the LATAM region and work in a hybrid model (remote and onsite as required)
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Bilingual in Spanish and English